Randomized, Open Study to Assess the Impact of Two Different Types of Food on the Relative Bioavailability of Fexinidazole Tablets After Single Oral Dose in Healthy Male Volunteers

Drugs for Neglected Diseases1 site in 1 country12 target enrollmentFebruary 2011

ConditionsPK in Healthy Volunteers

InterventionsFexinidazole

DrugsFexinidazole

Overview

Phase: Phase 1
Intervention: Fexinidazole
Conditions: PK in Healthy Volunteers
Sponsor: Drugs for Neglected Diseases
Enrollment: 12
Locations: 1
Primary Endpoint: Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is designed to assess the impact of concomitant food intake on the relative bioavailability of a single oral fexinidazole tablet administration.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

April 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Drugs for Neglected Diseases

Eligibility Criteria

Inclusion Criteria

•Male healthy volunteers 18 to 45 years of age,
•All subjects to be of sub-Saharan African origins with both parents of sub- Saharan African origins too,
•Male subjects with a body mass index (BMI) calculated as weight in kg/(height in m2) from 18 to 28 kg/m2 at screening,
•Able to communicate well with the Investigator and research staff and to comply with the requirements of the entire study,
•Provision of written informed consent to participate as shown by a signature on the volunteer consent form,
•Light smokers (less than 10 cigarettes per day) or subjects who are non-smokers. No smoking (or use of smoking substitute e.g. nicotine patch) is permitted from screening throughout the study,
•Normal arterial blood pressure (BP) and pulse rate or, if abnormal, considered not clinically significant by the principal Investigator. These will be measured after resting for 5 min,
•Registered with the French Social Security in agreement with the French law on biomedical experimentation.

Exclusion Criteria

•Who on direct questioning and physical examination have evidence of any clinically significant acute or chronic disease, including known or suspected Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection,
•With any clinically significant abnormality following review of pre-study laboratory tests (aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT) and alkaline phosphatase (ALP) must be within normal ranges), vital signs, full physical examination and Electrocardiogram (ECG),
•Who are within the exclusion period defined in the National Register for Healthy Volunteers of the French Ministry of Health,
•Who forfeit their freedom by administrative or legal award or who were under guardianship,
•Unwilling to give their informed consent,
•Who have a positive laboratory test for Hepatitis B surface antigen (HbsAg), or anti-HIV 1/2 or anti- HCV antibodies
•Who have a history of allergy, intolerance or photosensitivity to any drug,
•Who have a history of serious allergy, asthma, allergic skin rash or sensitivity to any drug,
•Who are known or suspected alcohol or drug abusers (more than 14 units of alcohol per week, one unit = 8 g or about 10 mL of pure alcohol),
•Who drink more than 8 cups daily of beverage containing caffeine,

Arms & Interventions

Fasting

Treatment A: 1200mg fexinidazole administered in fasting conditions by oral route

Intervention: Fexinidazole

Meal 1: Plumpy Nuts

Treatment B: 1200mg fexinidazole administered in fed conditions (meal 1) by oral route

Intervention: Fexinidazole

Meal 2: Rice + beans

Treatment B: 1200mg fexinidazole administered in fed conditions (meal 2) by oral route

Intervention: Fexinidazole

Outcomes

Primary Outcomes

Plasma concentration measurement of fexinidazole, fexinidazole sulfoxide and sulfone metabolites after a single oral dose of fexinidazole (1200mg) administration and under different food intake conditions